Crimping device for loading stents and prosthetic heart valves

ABSTRACT

Systems and devices for crimping a medical device and associated methods are disclosed herein. A crimping device configured in accordance with embodiments of the present technology can include, for example, a frame including a stationary plate, a movable member, and a plurality of blades arranged to form a channel and each including a pin that projects through a slot on the movable member and a corresponding slot on the stationary plate. The crimping device can be actuated to move the movable member relative to the stationary plate to drive the pins along paths defined by the slots to thereby drive the blades radially inward to crimp a medical device positioned within the channel.

This application is a continuation of U.S. patent application Ser. No.16/927,238, filed Jul. 13, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/615,144, filed Jun. 6, 2017, now U.S. Pat. No.10,709,591, the entire contents of each of which are incorporated hereinby reference.

TECHNICAL FIELD

The present technology relates generally to devices, systems, andmethods for reducing the size of a medical device. In particular, someembodiments of the present technology relate to compact crimping devicesfor reducing a size of prosthetic heart valve devices.

BACKGROUND

Medical devices, such as stents and prosthetic valve devices, can beintroduced into a lumen of a body vessel via percutaneouscatheterization techniques. These medical devices may be expandable froma first cross-sectional dimension that allows for percutaneous devicedelivery to a second cross-sectional dimension at a treatment site. Inthe expanded state, the medical device has a larger cross-sectionaldimension than the catheter used to deliver the medical device.Accordingly, a crimping device is typically used to crimp (i.e., reduce)a cross-sectional dimension of the medical device so that the medicaldevice can be loaded into the catheter and advanced to a treatmentlocation in the body. At the treatment location, the medical device canbe removed from the catheter and expanded (e.g., via self-expansion,balloon catheter expansion, or mechanical expansion means) to provide atreatment function.

Prosthetic heart valve devices (e.g., prosthetic mitral valve devices)can have a large cross-sectional dimension in the expanded staterelative to other medical devices (e.g., stents) delivered viapercutaneous catheterization techniques. For example, some prostheticmitral valves can have an expanded cross sectional dimension of 1.97inches or more. It is often desirable to package and store prostheticheart valve devices in their expanded state until just beforeimplantation into the patient. For example, prosthetic heart valvedevices can be stored in a sterile solution up until the time theprosthetic heart valve device is ready to be loaded into a deliverysystem for implantation. Therefore, it is often desirable to crimpprosthetic heart valve devices in the operating room and only a fewminutes before a procedure to implant the prosthetic heart valve device.Such procedures preclude pre-crimping by the manufacturer, and benefitfrom crimping devices that are highly portable and readily available asa sterile system.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent. The headings provided herein are forconvenience only.

FIG. 1 is an isometric view of a system for reducing the size of amedical device configured in accordance with some embodiments of thepresent technology.

FIGS. 2 and 3 are isometric views of a crimping device of the system ofFIG. 1 in a first position and a second position, respectively, inaccordance with embodiments of the present technology.

FIG. 4 is a partially exploded view of the crimping device shown inFIGS. 2 and 3.

FIG. 5 is an isometric view of a blade of the crimping device shown inFIGS. 2-4 configured in accordance with some embodiments of the presenttechnology.

FIG. 6 is an isometric view of a medical device holder for use with thesystem shown in FIG. 1 and releasably coupled to a portion of aprosthetic heart valve device in accordance with some embodiments of thepresent technology.

FIGS. 7 and 8 are an isometric view and cross-sectional view,respectively, illustrating the medical device holder of FIG. 6 coupledto the crimping device of FIGS. 2-4 in accordance with embodiments ofthe present technology.

FIG. 9 is a top view of a tray of the system of FIG. 1 configured inaccordance with various embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is generally directed to systems includingcrimping devices for reducing the size of prosthetic heart valve devicesand other medical devices. The term “crimp” (e.g., used in relation to acrimping device or a crimping method) can refer to devices and methodsthat compact or compress a medical device to a smaller size. Specificdetails of several embodiments of the present technology are describedherein with reference to FIGS. 1-9. Although many of the embodiments aredescribed with respect to devices, systems, and methods for crimping,loading, and delivering prosthetic heart valve devices to a nativemitral valve, other applications and other embodiments in addition tothose described herein are within the scope of the present technology.For example, at least some embodiments of the present technology may beuseful for delivering prosthetics to other native valves, such as thetricuspid valve or the aortic valve. It should be noted that otherembodiments in addition to those disclosed herein are within the scopeof the present technology. Further, embodiments of the presenttechnology can have different configurations, components, and/orprocedures than those shown or described herein. Moreover, a person ofordinary skill in the art will understand that embodiments of thepresent technology can have configurations, components, and/orprocedures in addition to those shown or described herein and that theseand other embodiments can be without several of the configurations,components, and/or procedures shown or described herein withoutdeviating from the present technology.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can referencerelative positions of portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter).

Overview

FIG. 1 shows an embodiment of a crimping and loading system 10 (“system10”) for reducing the size of a medical device in accordance with thepresent technology. In particular, the system 10 can be used to crimp orcompact the medical device to enable the medical device to be loadedinto a delivery system for percutaneously delivering the medical deviceto a patient. In some embodiments, the medical device can be aprosthetic heart valve device. More particularly, the medical device canbe a mitral valve device for implantation into a native mitral valve andthe delivery system can be a delivery system for delivering the mitralvalve device to the native mitral valve, such as one or more of themitral valve devices and/or delivery systems disclosed in (1)International Patent Application No. PCT/US2014/029549, filed Mar. 14,2014, (2) International Patent Application No. PCT/US2012/061219, filedOct. 19, 2012, (3) International Patent Application No.PCT/US2012/061215, filed Oct. 19, 2012, (4) International PatentApplication No. PCT/US2012/043636, filed Jun. 21, 2012, (5) U.S. patentapplication Ser. No. 15/490,047, filed Apr. 18, 2017, and (6) U.S.patent application Ser. No. 15/490,008, filed Apr. 18, 2017, each ofwhich is incorporated herein by reference in its entirety.

As shown in FIG. 1, the system 10 includes a crimping device 100, amedical device holder 200 (“holder 200”), a tray 300, and a stand 400.The crimping device 100 includes a plurality of blades (not visible;described in further detail below) that define a channel 115 configuredto receive a medical device in an expanded state, and an actuatingmember 105 operably coupled to the blades. The actuating member 105 canbe manipulated by a user to vary or reduce a cross-sectional dimension(e.g., a diameter) of the channel 115 and, thereby, reduce the outerdimension of the medical device positioned within the channel 115. Insome embodiments, the holder 200 is releasably coupled to the medicaldevice, and then detachably coupled to an entry side 101 of the crimpingdevice 100 such that the holder 200 positions the medical deviceappropriately within the channel 115 of the crimping device 100 beforeand/or during crimping.

As shown in FIG. 1, the crimping device 100 can be positioned at leastpartially within a reservoir 310 in the tray 300. In some embodiments,the tray 300 includes a plurality of flanges 305 that project into thereservoir 310 and define a recess 315 that is sized and shaped to retainthe crimping device 100 such that the channel 115 is positioned withinthe reservoir 310. In other embodiments, the tray 300 can includedifferent or additional features for retaining and appropriatelypositioning the crimping device 100 within the tray 300, such asfasteners, interlocking surfaces, and/or other suitable retentionfeatures. The reservoir 310 can hold a liquid (e.g., chilled saline)that submerges the channel 115 when the crimping device 100 ispositioned within the recess 315. As further shown in FIG. 1, the tray300 can also include an aperture 320 for receiving a portion of adelivery system 600 therethrough and to facilitate loading the crimpedmedical device into the delivery system 600. For example, an elongatedcatheter body 605 and/or delivery capsule 610 of the delivery system 600can be inserted through the aperture 320 and positioned adjacent to thechannel 115 on an exit side 103 of the crimping device 100. In someembodiments, the tray 300 can further include one or more sealingmembers (not shown) positioned within the aperture 320 to at leastpartially seal liquid within the reservoir 310 when the delivery systemis moved into and out of the reservoir 310. The stand 400 can bepositioned to support a portion of the catheter body 605 and/or alignthe delivery system 600 with the aperture 320 of the tray 300. In otherembodiments, the system 10 can include additional components or some ofthe features may be omitted.

In operation, the crimping device 100 is positioned within the recess315 of the tray 300. A medical device, such as a prosthetic heart valvedevice, is releasably attached to the holder 200 while the medicaldevice is in its expanded state (e.g., an unconstrained state), and thenthe holder 200 is attached to the entry side 101 of the crimping device100 such that the medical device extends into the channel 115. In someembodiments, the holder 200 is attached to the entry side 101 of thecrimping device 100 before the crimping device 100 is positioned withinthe recess 315 of the tray 300. In some embodiments, the medical devicecan be packaged with and pre-attached to the holder 200. In someembodiments, the holder 200 is omitted, and the medical device can beplaced in the channel 115 by itself and/or releasably attached toanother portion of the crimping device 100 to retain the medical devicein the channel 115. Before or after the medical device is positioned inthe channel 115, the reservoir 310 of the tray 300 can be filled with aliquid (e.g., chilled saline) such that the channel 115 of the crimpingdevice 100 and the medical device positioned therein are submerged inthe liquid. Submerging the medical device can keep the medical devicechilled as the crimping device 100 acts on the medical device to reducethe outer dimension of the medical device.

When the system 10 is used to facilitate loading of the device into thedelivery system 600, a distal portion of the catheter body 605 can bepositioned through the aperture 320 such that the delivery capsule 610at the distal end of the catheter body 605 is positioned at the exitside 103 of the crimping device 100 adjacent the channel 115. In someembodiments, a distal nose cone of the delivery capsule 610 and anelongated central shaft attached thereto are inserted at least partlythrough the channel 115 and the unconstrained medical device (e.g.,toward the entry side 101 of the crimping device 100 beyond a distal endof the medical device). The stand 400 can be positioned to support thecatheter body 605 and/or other portions of the delivery system 600outside of the tray 300, and to align the delivery system 600 with theaperture 320 of the tray 300 and the channel 115 of the crimping device100.

Once the delivery system 600 and the medical device are properlypositioned with respect to the crimping device 100, a user canmanipulate the actuating member 105 of the crimping device 100 to reducethe cross-sectional dimension of the channel 115, and thereby reduce theouter dimension of the medical device (i.e., “crimp” the medicaldevice). In some embodiments, the medical device is crimped toaccommodate sizing of the delivery capsule 610 for implanting themedical device using a minimally invasive procedure. In someembodiments, reducing the cross-sectional dimension of the channel 115disengages the holder 200 from the medical device such that the medicaldevice is no longer attached to the holder 200 to allow for subsequentremoval of the medical device from the channel 115 (e.g., via the exitside 103 or the entry side 101 of the crimping device 100).

Once the medical device has been crimped, the medical device can beloaded into the delivery system 600 for subsequent delivery to apatient. For example, a portion of the delivery system 600 can beconfigured to engage the medical device and pull the crimped medicaldevice into the delivery capsule 610 and/or the catheter body 605. Insome embodiments, a piston device of the delivery system 600 engageswith features of the medical device, and is then retracted to pull themedical device into the delivery capsule 610. In some embodiments, thechannel 115 of the crimping device 100 has a generally funnel-like shapein which the diameter of the channel 115 decreases along an axis fromthe entry side 101 to the exit side 103 (i.e., away from the holder 200and toward the delivery capsule 610. In such embodiments, pulling themedical device into the delivery capsule 610 can further crimp a portionof the medical device as the medical device is pulled from awider-diameter portion of the channel 115 and through anarrower-diameter portion of the channel 115. In some embodiments, themedical device is pulled into the delivery system 600 while submerged inthe liquid within the reservoir 310. This is expected to inhibit airpockets or air bubbles from forming in the delivery system 600 as themedical device is loaded. Once the medical device is loaded in thedelivery system 600, the delivery system 600 can be withdrawn from thetray 300 and subsequently used to implant the medical device in apatient. In some embodiments, the system 10 is configured to be acompletely disposable system. Accordingly, the various components of thesystem 10, including the crimping device 100, can be disposed of (ascompared to being cleaned for subsequent re-use) after the medicaldevice is loaded into the delivery system. By making the system 10disposable, the system 10 can be provided as a new, sterile environmentprior to each procedure.

Selected Embodiments of Crimping Devices, Medical Device Holders, andAssociated Methods

FIGS. 2 and 3 are isometric views of the crimping device 100 of FIG. 1illustrating the crimping device 100 in a first position with thechannel 115 having a first cross-sectional dimension (FIG. 2) and in asecond position with the channel 115 having a second cross-sectionaldimension (FIG. 3). FIG. 4 is an isometric partially exploded view ofthe crimping device 100 of FIG. 2 (i.e., showing the crimping device 100in the first position). In some embodiments, the first and secondcross-sectional dimensions are a maximum and a minimum cross-sectionaldimension, respectively. The crimping device 100 includes a frame 110, aplurality of movable blades 140 arranged circumferentially within theframe 110 to define the channel 115 having a central axis 107 extendingtherethrough.

Referring to FIG. 4, the frame 110 can include a first plate 120 havinga plurality of first slots 122 extending through portions of the firstplate 120, and a second plate 130 having a plurality of second slots 132extending through portions of the second plate 130 (collectivelyreferred to as “plates 120, 130”). The crimping device 100 furtherincludes a first movable member 160 and a second movable member 170(collectively “movable members 160, 170”) that are movable (e.g.,rotatable) with respect to the first and second plates 120 and 130. Forexample, the movable members 160, 170 can be configured to rotate aboutthe central axis 107 of the channel 115. The first movable member 160 ispositioned between the blades 140 and the first plate 120, and the firstmovable member 160 includes a plurality of third slots 162 extendingthrough portions of the first movable member 160. Similarly, the secondmovable member 170 is positioned between the blades 140 and the secondplate 130, and the second movable member 170 includes a plurality offourth slots 172 extending through portions of the second movable member170. Portions of the first slots 122 can be aligned with portions of thethird slots 162, and portions of the second slots 132 can be alignedwith portions of the fourth slots 172. In some embodiments, the firstand second slots 122 and 132 (collectively referred to as “slots 122,132”) and the third and fourth slots 162 and 172 (collectively referredto as “slots 162, 172”) are reflectively symmetric about a planeextending perpendicularly to the central axis 107 of the channel 115.

Each blade 140 can include a pin 142 that projects from a portion of theblade 140 spaced apart from the central axis 107 (e.g., an outer portionof the blade 140). At the exit side 103 of the crimping device 100, eachpin 142 extends through one of the first slots 122 of the first plate120 and a corresponding one of the third slots 162 of the first movablemember 160, and at the entry side 101 of the crimping device 100 eachpin 142 extends through one of the second slots 132 and a correspondingone of the fourth slots 172 of the second movable member 170.Accordingly, the quantity of slots 122, 132, 162, 172 on each of theplates 120, 130 and the movable members 160, 170 can correspond to thequantity of blades 140. In operation, a user can manipulate theactuating member 105 to rotate, slide, or otherwise move the first andsecond movable members 160 and 170 relative to the first and secondplates 120 and 130. This drives the pins 142 along paths defined bycorresponding slots 122, 132, 162, 172, thereby driving the blades 140radially inward to decrease the cross-sectional dimension of the channel115 (FIG. 3). The radially inward movement of the blades 140 acts on anouter surface of a medical device (e.g., a prosthetic heart valvedevice) positioned within the channel 115 and, thereby, reduces theouter cross-sectional dimension (e.g., diameter) of the medical deviceto fit within a delivery capsule (e.g., the delivery capsule 610 of FIG.1). In some embodiments, the second plate 130 and the second movablemember 170 are omitted such that the relative movement of the firstplate 120 and the first movable member 160 alone drive the inward motionof the blades 140.

The plates 120, 130 can have a generally rectangular shape such that theframe 110 has a generally rectangular cross-section. In otherembodiments, the plates 120, 130 can have other shapes such as, forexample, circular, hexagonal, polygonal, etc., and can have differentshapes from one another. For example, when the plates 120, 130 have acircular shape, the frame 110 can include a stabilizing base region. Insome embodiments, the plates 120, 130 can be internal componentspositioned within an outer housing that defines the frame 110. The frame110 can have a shape configured to fit snugly within the recess 315(FIG. 1) of the tray 300. The actuating member 105 can be positioned onan upper surface 112 (FIG. 2) of the frame 110 such that it isaccessibly to a user during a crimping procedure. In other embodiments,the actuating member 105 may be positioned elsewhere on the frame 110,or may be an electric motor instead of a manual actuator. As shown inFIG. 4, the plates 120, 130 are stationary relative to the movablemembers 160, 170. In some embodiments, the first plate 120 is movablerelative to the first movable member 160 and/or the second plate 130 ismovable relative to the second movable member 170 to drive the blades140 radially inward. For example, manipulating the actuating member 105can rotate the first plate 120 in an opposite direction as the firstmovable member 160.

The first and second slots 122 and 132 can each define a straight pathextending radially away from the central axis of the channel 115. Asshown in FIG. 4, each plate 120, 130 can include twelve slots 122, 132spaced at equal intervals around the central axis 107 of the channel115. However, in some embodiments, each plate 120, 130 can include fewerthan or more than twelve slots (e.g., six slots, eight slots, fourteenslots, etc.) depending on the quantity of blades 140, and/or the slots122, 132 can be arranged in other configurations and can have differentshapes. For example, one or more of the slots 122, 132 can define agenerally arcuate or other path. As illustrated in FIG. 4, the secondslots 132 can have generally similar features to the first slots 122. Inother embodiments, the second slots 132 can have a different numberand/or have a different configuration, shape, etc. from the first slots122.

The third slots 162 on the first movable member 160 can each define anarcuate or angled path having a first end 163 a and a second end 163 bspaced radially closer to the central axis of the channel 115 than thefirst end 163 a. In some embodiments, the first movable member 160includes twelve arcuate slots 162 spaced apart from each other at equalintervals around the central axis 107 of the channel 115. In otherembodiments, the plurality of third slots 162 can include fewer than ormore than twelve slots (e.g., eight slots) depending on the quantity ofblades 140, and can be arranged in other configurations and can havedifferent shapes. For example, the third slots 162 can define agenerally straight path, or could have a concave portion that facesradially outward from the central axis of the channel 115. Althoughpartly obscured in FIG. 4, the fourth slots 172 can have generallysimilar features to the third slots 162. In some embodiments, the slots162, 172 are reflectively symmetric about a plane extendingperpendicularly to the central axis 107 of the channel 115. In otherembodiments, the slots 162, 172 can each comprise a different number ofslots, and/or have different configurations, shapes, etc. from oneanother. Moreover, as shown in FIG. 4, the slots 162, 172 can be longerthan the slots 122, 132 in the plates 120, 130. In some embodiments, theslots 162, 172 extend radially the same or a substantially similardistance as the slots 122, 132.

The first through fourth slots 122 132, 162, 172 define a path ofmovement for the pins 142. For example, the first and second slots 122and 132 can be sized and shaped to maintain the position of theindividual blades 140 relative to each other, and the third and fourthslots 162 and 172 can be sized and shaped to drive the blades 140radially inward or outward. Accordingly, movement of the pins 142 alongthe slot paths causes the blades 140 to slide relative to each other andto move radially inward or outward. For example, movement of the firstmovable member 160 relative to the first plate 120 drives the pins 142along the path defined by the third slots 162 of the first movablemember 160 and constrained by the path of the first slots 122 of thefirst plate 120. Similarly, movement of the second movable member 170relative to the second plate 130 drives the pins 142 along the pathdefined by the fourth slots 172 of the second movable member 170 andconstrained by the path of the second slots 132 of the second plate 130.When the pins 142 are in an initial or first pin position (FIG. 2), theblades 140 are arranged such that the channel 115 has a maximumcross-sectional dimension (e.g., diameter), and the pins 142 arepositioned at a radially outer end 123 a (FIG. 2) of the first slots 122and a radially outer end 162 a (FIG. 4) of the third slots 162. When thepins 142 are in a final or second pin position (FIG. 3), the pins 142are positioned at a radially inner end 123 b (FIG. 3) of the first slots122 and a radially inner end 162 b (FIG. 4) of the third slots 162, andthe channel 115 has a minimum cross-sectional dimension. Accordingly,the pins 142 can move between the first and second pin positions toreduce and expand the cross-sectional dimension of the channel 115. Inother embodiments, the pins 142 can be positioned at different locations(e.g., positioned at an intermediate location) along the first slots 122when in the first and/or second pin configuration. When the medicaldevice is positioned within the channel 115, driving the pins 142radially inward can reduce a cross-sectional dimension (e.g., diameter)of the medical device. In some embodiments, such as embodimentsincluding twelve blades 140, the blades 140 are configured to reduce anouter diameter of a prosthetic heart valve device from about 1.67 inches(42.42 mm) to 0.4 inch (10.16 mm) or less. For example, the blades 140can be configured to completely close the channel 115 in the second pinposition (i.e., a cross-sectional dimension of the channel 115 is zero).As another example, in embodiments including eight blades 140, theblades 140 can be arranged such that the channel 115 has a maximum outerdiameter of about 1.3 inches (33.02 mm) and can reduce the diameter ofthe channel 115 to 0.4 inch (10.16 mm) or less. The maximum and minimumcross-sectional dimensions of the channel 115 can depend on the quantityof blades 140, the size and shape of the blades 140, the locations ofthe pins 142 on the blades 140, and/or the travel path of the blades 140as defined by the slots 122, 132, 162, 172.

As shown in FIG. 4, the second plate 130 includes a plurality of firstconnective features 133 and a plurality of second connective features135. The first connective features 133 can be holes, flanged surfaces,and/or other attachment mechanisms configured to releasably couple themedical device holder 200 (FIG. 1) to the second plate 120 of the frame110. The second connective features 135 are configured to provide anattachment mechanism for forming the frame 110 (e.g., connecting thefirst plate 120 to the second plate 130). As shown, the secondconnective features 135 can be hooks or fasteners shaped to mate withcorresponding holes 125 on the first plate 120. In some embodiments, thesecond connective features 135 permit the frame 110 of the crimpingdevice 100 to be taken apart to, for example, permit cleaning of theindividual components within the frame (e.g., the blades 140 and movablemembers 160, 170). In some embodiments, the first and second plates 120and 130 can be fixedly attached to each other via bonding, welding,and/or other attachment methods.

As further shown in FIG. 4, the crimping device 100 can also include anactuator device 150 operably coupled to the first and second movablemembers 160 and 170, and configured to move the first and second movablemembers 160, 170 relative to the first and second plates 120 and 130. Insome embodiments, as shown in FIG. 4, the actuator device 150 includesthe actuating member 105 coupled to a threaded shaft 152 and a connector154 having a threaded shaft 156 extending therethrough. The connector154 couples to portions of the first and second movable members 160,170. Turning the actuating member 105 rotates the threaded shaft 152about a longitudinal axis of the threaded shaft 152, which in turn movesthe connector 154 along the length of the threaded shaft 152. Movementof the connector 154 moves the first and second movable members 160,170, thereby driving the pins 142 inward or outward along the pathsdefined by the slots 122, 132, 162, 172 of the plates 120, 130 and themovable members 160, 170. For example, a user can turn the actuatingmember 105 in a first direction to cause the connector 104 to movedownwards (i.e., towards the bottom of the page) in order to rotate thefirst and second movable members 160, 170 clockwise about the centralaxis 107 of the channel 115. Clockwise rotation of the first and secondmovable members 160, 170 can drive the pins 142 inward along thecombined paths of the first and third slots 122, 162 and second andfourth slots 132, 172 to reduce the cross-sectional dimension of thechannel 115. Turning the actuating member 105 in the opposite directioncan rotate the movable members 160, 170 in the counterclockwisedirection to drive the pins 142 outward along the combined paths of thefirst and third slots 122, 162 and second and fourth slots 132, 172 toincrease the cross-sectional dimension of the channel 115. In someembodiments, the actuator device 150 can be configured to rotate theblades 140 in the opposite directions to effectuate device compression.The actuator device 150 illustrated in FIG. 4 provides for continuous(e.g., rather than stepwise) compression of a medical device placedwithin the channel 115 of the crimping device 100, and can have arelatively smaller footprint as compared to other types of actuators.

In some embodiments, the actuator device 150 can comprise a differentmechanism to drive movement of the movable members 160, 170, and/or theactuator device 150 can be coupled to the movable members 160, 170 in adifferent manner. For example, in some embodiments, the actuator device150 can comprise a lever coupled to the movable members 160, 170. Inother embodiments, the movable members 160, 170 can be configured toslide (i.e., rather than rotate) relative to the plates 120, 130. Insuch embodiments, the actuator device 150 may comprise a handle or othergripping mechanism for sliding the movable members 160, 170. In stillother embodiments, the actuator device 150 may include an electric motorconfigured to move the movable members 160, 170.

FIG. 5 is an isometric view of one of the blades 140 of the crimpingdevice 100 (FIGS. 1-4). Each blade 140 can include a first end portion141 a, a second end portion 141 b, a first side 143 a, and a second side143 b. The pin 142 of each blade 140 can include a first pin portion 142a projecting from the first side 143 a of the blade 140 (e.g., towardthe entry side 101 of the crimping device 100 of FIGS. 1-4), and asecond pin portion 142 b projecting from the second side 143 b of theblade 140 (e.g., toward the exist side 103 of the crimping device 100 ofFIGS. 1-4). The first pin portion 142 a and the second pin portion 142 b(collectively referred to as “pin portions 142 a, 142 b”) can be asingle component (e.g., a single shaft) extending through and/orintegrally formed with the blade 140, or the pin portions 142 a, 142 bcan be separate pin components that project from either side of theblade 140. In some embodiments, some or all of the blades 140 caninclude only the first pin portion 142 a or only the second pin portion142 b. As shown in FIG. 5, the pin portions 142 a, 142 b project fromthe second end portion 141 b of the blade 140. When the blade 140 ispositioned within the crimping device 100, the second end portion 141 bis spaced apart from and radially farther from the central axis 107 ofthe channel 115 than the first end portion 141 a. Accordingly, the pinportions 142 a, 142 b project from a radially outer portion of the blade140. Compared to a blade with a pin positioned at a central or moreradially inward position of the blade, this radially outward positioningof the pin 142 requires less actuation (i.e., the pin 142 need not bedriven as far) to produce an equal amount of inward movement of theblade 140. As a result, the overall size of the crimping device 100 isreduced while still maintaining a sufficiently large crimping range(e.g., the range between a minimum and maximum cross-sectional dimensionof the channel 115) to accommodate the sizing of a medical device in anexpanded state and the sizing of a delivery system (e.g., a deliverycapsule).

As further shown in FIG. 5, the blade 140 includes an inner surface 146a and an outer surface 146 b. In general, the inner and outer surfaces146 a and 146 b are configured to enable adjacent blades 140 to sliderelative to one another and to define a shape of the channel 115 of thecrimping device 100. More specifically, the inner surface 146 a can begenerally sloped along an axis extending between the first and secondsides 143 a and 143 b of the blade 140 (e.g., along the central axis 107of the channel 115 shown in FIGS. 2-4). The outer surface 146 b can havea portion that is generally shaped to match the shape of the innersurface 146 a of an adjacent blade 140, and is configured to slideagainst the inner surface 146 a of an adjacent blade 140 as the pinportions 142 a, 142 b are actuated (e.g., driven radially inward oroutward along the slots 122, 132 and slots 162, 172).

A portion of the inner surfaces 146 a (e.g., a portion not covered bythe outer surface 146 b of an adjacent blade 140) of the blades 140collectively define the channel 115 of the crimping device 100. When theblades 140 with a sloped inner surface 146 a are arrangedcircumferentially, the channel 115 can have a generally funnel-likeshape (e.g., as shown in FIG. 8). That is, the channel 115 can have alarger cross-sectional dimension closer to the second sides 143 b of theblades 140 (e.g., proximate to the second plate 130 at the entry side101 of the crimping device 100) than the first sides 143 a of the blades140 (e.g., proximate the first plate 120 at the exit side 103 of thecrimping device). In other embodiments, the inner and outer surfaces 146a , 146 b of the blade 140 can have other shapes or arrangements. Forexample, the inner surfaces 146 a of each blade can have a wedge-likeshape such that the channel 115 has a constant cross-sectional dimensionalong the central axis of the channel 115. In yet other embodiments, theblades 140 can generally have any other shape or configuration so as toform a channel 115 with a varying cross-sectional dimension along thecentral axis 107 of the channel 115. In some embodiments, the innerand/or outer surfaces 146 a , 146 b of the blade 140 can include one ormore grooves, slots, holes, etc. These features can reduce the weight ofthe blade 140 to thereby increase the portability of the crimping device100, without affecting the function or strength of the crimping device100.

In some embodiments of the present technology, the crimping device 100can omit one or more of the components described above with reference toFIGS. 2-5. For example, the crimping device 100 can include only one ofthe movable members 160, 170, and each blade 140 may include only one ofthe pin portions 142 a or 142 b to drive the blades 140 inward to reducethe size of a medical device. However, redundancy of the two movablemembers 160, 170 and the two plates 120, 130 at the first and secondsides 101 and 103 of the crimping device 100 effectively supports eachblade 140 at both the first and second side 143 a, 143 b of the blade140. Including two movable members 160, 170 can also decrease the amountof force required to actuate the blades 140, and can facilitate at leastsubstantially equal distribution of the actuating force across theblades 140 between the first and second sides 143 a, 143 b. In someembodiments, the crimping device 100 can include fewer than twelveblades (e.g., four blades, five blades, six blades, eight blades, etc.)or more than twelve blades (e.g., sixteen blades, twenty blades, etc.),and the quantity of slots 122, 132, 162, 172 of the movable members 160,170 and the plates 120, 130 can be modified to correspond to the numberof blades 140.

Each of the components described above with reference to FIGS. 2-5 canbe made from the same or different materials, such as metals, polymers,plastic, composites, combinations thereof, and/or other materials. Thecomponents of the crimping device 100 can be manufactured using suitableprocesses, such as, for example, three-dimensional printing, injectionmolding, and/or other processes for supporting and compressing a medicaldevice during a crimping procedure. In some embodiments, each componentis made from a suitable plastic or polymer such that the system iscompletely disposable and able to be manufactured at a relatively lowcost. In some embodiments, some of the components illustrated herein asindividual components can be integrally formed together or otherwisecombined.

In use, the crimping device 100 can provide a compact, yet efficientmechanism for reducing the size of a prosthetic heart valve device orother medical device. The slots 122, 132 of the plates 120, 130 and theslots 162, 172 of the movable members 160, 170 define paths for the pins142 that slide the blades 140 radially inward relative to each other toreduce the diameter of the channel 115. This radially inward force iscontinuous along the surfaces of the blades 140 contacting the medicaldevice within the channel 115, and therefore provides continuouscompression of the medical device. As such, the continuous compressionallows the user to pause or terminate the crimping procedure at any time(i.e., not just at the maximum and minimum diameters of the channel115). Further, the funnel-like shape of the channel 115 provided by theblade shape allows portions of the medical device to be compressed morethan other portions during inward movement of the blades. For example, alarger portion of the medical device may be positioned in the largerportion of the channel 115 (e.g., toward the entry side 101 of thecrimping device 100) and not undergo as much compression as the portionof the medical device positioned in the smaller portion of the channel115 (e.g., toward the exit side 103 of the crimping device 100). Thiscan inhibit the compressive crimping forces from moving the medicaldevice laterally toward the entry side 101 of the crimping device 100and help retain the medical device within the channel 115 duringcrimping. In addition, the position of the pins 142 on the outerportions of the blades 140 reduces the length of the pin travel pathnecessary for inward movement of the blades 140 to achieve the desiredcrimping range. For example, the pins 142 can travel a distance of 0.26inch (6.604 mm) to reduce the channel diameter from about 1.3 inches to0.4 inch or less. Thus, the arrangement of the pins 142, the blades 140,the movable members 160, 170, and the plates 120, 130, in conjunctionwith the actuator device 150, allows the crimping device 100 to have acompact size that can easily be moved by a clinician to and from asterile field, while still providing for a large crimping range suitablefor reducing the size of prosthetic heart valves to allow forpercutaneous delivery of the device.

FIG. 6 is an isometric view showing the medical device holder 200(“holder 200”) configured in accordance with an embodiment of thepresent technology and coupled to an exemplary medical device 500. Insome embodiments as shown in FIG. 6, the medical device 500 is a valvesupport for use with a prosthetic heart valve device. The holder 200includes a base 202 having a first side 203 a, a second side 203 b, andan opening 205 extending therebetween. The base 202 can include aplurality of connectors 201 on the second side 203 b and configured toremovably couple the holder 200 to the crimping device 100 (e.g., to theconnective features 113 of the second plate 130 of FIGS. 2-4). As shownin FIG. 6, the base 202 can have a generally annular shape including aradially outer surface 209 a and a radially inner surface 209 b, bothextending between the first and second sides 203 a, 203 b. The outersurface 209 a can include a plurality of grooves 207 and/or ridges tomake the holder 200 easy to grip and manipulate, even while submergedduring the crimping process. The holder 200 further includes a pluralityof first fingers 206 and a plurality of second fingers 208 (collectively“fingers 206, 208”) projecting from the base 202 and arrangedcircumferentially around a central axis extending through the opening205 of the base 202. The fingers 206, 208 are configured to engage atleast a portion of the medical device 500 to hold the medical device 500within the channel 115 of the crimping device 100 (FIGS. 2-4) during atleast an initial portion of a crimping procedure.

As shown in FIG. 6, the first fingers 206 can be spaced around thecentral axis of the opening 205 to engage the medical device 500 at morethan one point around a circumference of the medical device 500. Thefirst fingers 206 include a first portion 206 a extending radiallyinward from the inner surface 209 b of the base 202 toward the centralaxis of the opening 205, a second portion 206 b extending from the firstportion 206 a and away from the second side 203 b of the base 202, athird portion 206 c extending from the second portion 206 b and radiallyinward toward the central axis of the opening 205, and a fourth portion206 d configured to engage the medical device 500. The fourth portion206 d can include an index feature 206 e shaped to engage a portion ofthe medical device 500. For example, as shown in FIG. 6, the medicaldevice 500 can be a stent-device including a frame 580 comprising aplurality of frame cells 582. Each frame cell 582 can have a hexagonalshape and comprise a pair of first struts 583, a pair of second struts584, and a pair of third struts 585. Each of the first struts 583 canextend from an end of the second struts 584, and pairs of the firststruts 583 can be connected together to form V-struts 586. At least someof the V-struts 586 at an end portion of the frame 580 can define anapex 587. As shown, the index features 206 e can have a generally V-likeshape to engage (e.g., mate with) an individual V-strut 586 of themedical device 500. In other embodiments, the medical device 500 and/orthe first fingers 206 can have other suitable shapes that enable thefirst fingers 206 to engage a portion of the medical device 500. Forexample, the medical device 500 may be a stent device having frame cells582 with a rectangular, sinusoidal, triangular, polygonal, or othershape, and the index features 206 e can have a corresponding shape andarrangement that mates with or fits within a portion of the frame cells582. In some embodiments, the first fingers 206 are configured to engagewith the atrial end of a valve support of a prosthetic mitral valvedevice and/or other atrial portions of the prosthetic mitral valvedevice. In some embodiments, the first fingers 206 are configured toengage with the ventricular side of the valve support and/or otherventricular portions of the prosthetic mitral valve device.

In some embodiments, the first fingers 206 are flexible such that theybend radially inward or outward in response to external forces appliedto the first fingers 206. For example, when the holder 200 is notattached to the medical device 500, the fourth portions 206 d of thefirst fingers 206 can be positioned a distance away from the centralaxis of the opening 205 that is slightly greater than a cross-sectionaldimension of the medical device 500. To attach the medical device 500,the first fingers 206 can be bent radially inward until the fourthportions 206 d of the first fingers 206 are within the medical device500, and then released. Accordingly, the index features 206 e of thefirst fingers 206 can press against (e.g., the first fingers 206 areslightly radially biased outward against) a radially interior side ofthe medical device 500 to hold or grip the medical device 500. The indexfeatures 206 e can prevent the medical device 500 from slipping off ofthe holder 200 when no other forces are applied to the first fingers206. When the holder 200 is attached to the crimping device 100 (FIGS.1-4), the blades 140 can press down on the first fingers 206 as thechannel 115 decreases in size, thereby causing the first fingers 206 toflex inwardly and release the medical device 500 from the holder 200 forsubsequent loading into the delivery system 600 (FIG. 1).

The second fingers 208 can each include a first portion 208 a extendingradially inward from the inner surface 209 b of the base 202 toward thecentral axis of the opening 205, a second portion 208 b extending fromthe first portion 208 a and away from the second side 203 b of the base202, and a third portion 206 c extending from the second portion 208 band radially inward toward the central axis of the opening 205. Notably,the first portion 208 a of each second finger 208 is longer than thefirst portion 206 a of each first finger 206. The second portions 206 bof the first fingers 206 are therefore positioned radially farther fromthe central axis of the opening 205 than the second portions 208 b ofthe second fingers 208. As shown, the third portions 208 c of the secondfingers 208 can be shaped and positioned to receive the apexes 587 ofthe medical device 500. The second fingers 208 can therefore provideadditional support for holding the medical device 500 in place. In someembodiments, the holder 200 can include fingers 206, 208 with othershapes, arrangements, quantities, etc., suitable for holding the medicaldevice 500 in place. For example, the holder 200 may comprise more orless than the twelve fingers 206, 208 shown in FIG. 6 (e.g., more orless than three first fingers 206 and more or less than nine secondfingers 208). In some embodiments, the holder 200 includes only thefirst fingers 206 or only the second fingers 208.

FIGS. 7 and 8 are an isometric view and a cross-sectional side view,respectively, illustrating the holder 200 of FIG. 6 coupled to thecrimping device 100 shown in FIGS. 2-4. For ease of illustration, themedical device 500 is not shown in FIGS. 7 and 8. Referring first toFIG. 7, the holder 200 can be removably coupled to the entry side 101 ofthe crimping device 100 via the second plate 130 of the frame 110. Morespecifically, the connectors 201 (shown in FIG. 6) of the holder 200 canconnect to the first connective features 133 disposed on the frame 110.In some embodiments, the connectors 201 are at least one of hooks,fasteners, clips, locking features, etc. that engage (e.g., mate with)the first connective features 133 to removably secure the holder 200 tothe crimping device 100. In some embodiments, the connectors 201 areinserted into the connective features 113, and the holder 200 is rotatedto secure the holder 200 in place. Once secured, the central axis of theopening 205 of the holder 200 can be generally aligned with the centralaxis 107 of the channel 115 of the crimping device 100. By aligning thecentral axes of the crimping device 100 and holder 200, the medicaldevice 500 can be evenly spaced with respect to the blades 140 withinthe channel 115 before the medical device 500 is crimped to facilitategenerally symmetric radial compression of the medical device 500.

As shown in FIG. 8, the fingers 206, 208 of the holder 200 can projectat least partly into the channel 115 of the crimping device 100.Accordingly, the fingers 206, 208 of the holder 200 can hold the medicaldevice 500 (FIG. 6) in a position that is fully within the channel 115.FIG. 8 further shows an embodiment in which the channel 115 has agenerally funnel-like shape in which a cross-sectional dimension (e.g.,diameter) of the channel 115 decreases along the central axis 107 movingfrom the entry side 101 of the crimping device 100 to the exit side 103of the crimping device 100.

Referring to FIGS. 6-8 together, to crimp the medical device 500, theactuating member 105 is manipulated as described above to reduce thediameter of the channel 115. As the diameter of the channel 115decreases, portions of the blades 140 can contact portions of the firstfingers 206 and/or portions of the second fingers 208 that are withinthe channel 115. Specifically, the blades 140 first contact the secondportions 206 b of the first fingers 206 because they are positionedradially farther from the central axis of the channel 115 than thesecond portions 208 b (FIG. 6) of the second fingers 208. As thediameter of the channel 115 is further decreased, the blades 140 exertan inward force against the second fingers 208 that bends the fingers208 radially inward and causes the fourth portions 206 d of the firstfingers 206 to disengage from the medical device 500. The blades 140 donot contact the first fingers 206 until after contacting the secondfingers 208 because the second portions 208 b of the second fingers 208are positioned radially closer to the central axis 107 of the channel115 than the second portions 206 b of the first fingers 206. Therefore,after the first fingers 206 disengage from the medical device 500, thethird portions 208 c of the second fingers 208 can still engage andsupport a portion of the medical device 500 (e.g., the apexes 587). Insome embodiments, the second fingers 208 can inhibit the medical device500 from moving laterally (e.g., translation between the opposing plates120, 130) while the medical device 500 is crimped. For example, thesecond fingers 208 can counteract the tendency of the medical device 500to move laterally toward the entry side 101 of the crimping device 100as a result of non-uniform compression of the medical device 500 causedby the funnel-like shape of the channel 115.

In some embodiments, the diameter of the channel 115 can be decreased toa small enough diameter to disengage the holder 200 from the medicaldevice 500 (e.g., disengage the first fingers 206), but maintain a largediameter such that the fingers 206, 208 positioned within the medicaldevice 500 do not interfere with the crimping of the medical device 500.For example, the holder 200 and the crimping device 100 can beconfigured such that the holder 200: (i) holds (e.g., is engaged withand grips) the medical device 500 when the channel 115 of the crimpingdevice 100 has a maximum diameter (e.g., the first position shown FIG.2), and (ii) is disengaged from the medical device 500 when the channel115 of the crimping device 100 has a minimum diameter (e.g., the secondposition shown FIG. 3). In some embodiments, the holder 200 can beremoved from the crimping device 100 after the holder 200 disengagesfrom the medical device 500. In such embodiments, the diameter of thechannel 115 can then be further decreased to further crimp the medicaldevice 500.

Selected Embodiments of Trays for Receiving a Crimping Device

FIG. 9 is a top view of the tray 300 of the crimping and loading system10 of FIG. 1 configured in accordance with embodiments the presenttechnology. The tray 300 can be formed using a thermoforming processand/or other suitable tray forming processes. As shown, the interiorwalls of the tray 300 define the reservoir 310 for holding a liquid(e.g., chilled saline). The reservoir 310 can include a first portion312, a second portion 314, and a third portion 316. The first portion312 can be sized and shaped to receive the crimping device 100 (FIGS.1-4) with the entry side 101 or the exit side 103 facing down against abottom surface of the tray 300 prior to use (e.g., during storage and/orshipping). The second portion 314 of the reservoir 310 is defined by theflanges 305 of the tray 300 and includes the recess 315 that isconfigured to retain the crimping device 100 (FIGS. 1-4) in a stableupright position during the crimping procedure. In some embodiments, thetray 300 includes a slot for introducing the liquid into the reservoir310. The slot can be configured to allow liquid to enter the reservoir310 in a non-turbulent manner, which is expected to inhibit air bubblesfrom forming in portions of the tray 300 or the crimping device 100. Forexample, in some embodiments, the slot provides a liquid flow path intothe first portion 312 of the reservoir 310.

The third portion 316 of the reservoir 310 can be positioned at the exitside 103 of the crimping device 100 (e.g., as shown in FIG. 1), and canprovide a region in which the crimped medical device can be loaded intoa delivery system (e.g., the delivery system of FIG. 1). In someembodiments, the third portion 316 of the reservoir 310 can also providean area to visualize the channel 115 of the crimping device 100 and/orportions of the delivery system positioned adjacent the crimping device100 (FIG. 1) during device loading. For example, the tray 300 caninclude slanted sidewalls (identified individually as a first slantedsidewall 317 a and a second slanted sidewall 317 b; referred tocollectively as “slanted sidewalls 317”) on which one or more mirrorscan be placed to provide alternate views of the crimping device 100(FIGS. 1-4) and/or the delivery system. In some embodiments, the tray300 has a generally flat lower surface in the third portion 316 with amirror disposed on the lower surface to provide for visualization duringdevice loading. The third portion 316 of the reservoir 310 can also beshaped to receive the stand 400 (FIG. 1) so that that the stand 400 canbe positioned in the third portion 316 prior to use (e.g., duringstorage and/or shipping). Accordingly, in some embodiments, eachcomponent of the system 10 (FIG. 1) can be securely positioned withindedicated portions of the tray 300 for shipping and storage. The system10 (FIG. 1) can therefore be provided to a physician in a streamlinedand sterile manner.

As further shown in FIG. 9, the walls of the tray 300 further includesthe aperture 320 for receiving a portion of a delivery system (e.g., thedelivery system 600 of FIG. 1) therethrough, and one or more grooves(identified individually as a first groove 319 a and a second groove 319b; referred to collectively as “grooves 319”) positioned on either sidethe aperture 320. The grooves 319 can be configured to receive a dammember (not pictured) for sealing the reservoir 310 and preventingliquid from escaping through the aperture 320. In some embodiments, aportion of a suitable delivery system can puncture the dam memberspositioned within the grooves 319 in order to position the portion ofthe delivery system adjacent the crimping device 100 (FIG. 1). In someembodiments, the tray 300 can include valve and/or sealing device thatis positioned on a sidewall of the tray 300 (e.g., in the aperture 320or other hole) and in fluid communication with the reservoir 310. Thevalve and/or sealing device can fluidically seal liquid in the reservoir310 before, during, and/or after a delivery system (e.g., the deliverysystem 600 of FIG. 1) has been moved therethrough. For example, a valve(e.g., a cross-slit valve, a one-way check valve, etc.) can be housedwithin a grommet (e.g., a molded silicone grommet) that is positioned inthe hole in the sidewall of the tray 300 to at least partially preventliquid from leaking from the reservoir 310 when the delivery system ismoved into and out of the valve member. In other embodiments, the tray300 can include other configurations of valves and/or sealing devices toseal liquid within the reservoir 310, while still allowing access to thereservoir 310 from a sidewall of the tray 300 for device loading oradjustment.

EXAMPLES

Several aspects of the present technology are set forth in the followingexamples.

1. A crimping device comprising:

a stationary plate having a plurality of first slots;

-   -   a movable member having a plurality of second slots, wherein the        individual second slots are aligned with a portion of the        corresponding individual first slots;    -   a plurality of movable blades arranged circumferentially to form        a channel having a central axis extending therethrough, wherein—        -   each blade has a first end portion and a second end portion,            and wherein the second end portion is radially farther from            the central axis than the first end portion,        -   each blade includes a pin projecting from the second end            portion of the blade, and    -   each pin extends through one of the first slots and a        corresponding one of the second slots; and    -   an actuator device operably coupled to the movable member and        configured to move the movable member relative to the stationary        plate, wherein movement of the movable member drives the        plurality of pins along a path defined by the first and second        slots such that the plurality of blades move radially inward to        decrease a diameter of the channel, and wherein the radial        inward movement of the blades is configured to reduce a diameter        of a medical device positioned within the channel to accommodate        sizing of a delivery capsule for implanting the medical device        using a minimally invasive procedure.

2. The crimping device of example 1 wherein the blades include a firstside and a second side facing away from the first side, the stationaryplate is a first stationary plate facing the first side of the blades,the movable member is a first movable member facing the first side ofthe blades, and each pin is a first pin on the first side of each blade,and wherein the crimping device further comprises:

-   -   a second stationary plate facing the second side of the blades,        the second stationary plate having a plurality of third slots;    -   a second movable member facing the second side of the blades,        the second movable member having a plurality of fourth slots,    -   wherein—        -   each blade includes a second pin projecting from the second            end portion on the second side of the blade,        -   each second pin extends through one of the third slots and a            corresponding one of the fourth slots, and        -   the actuator device is operably coupled to the first and            second movable members and configured to move the first and            second movable members relative to the first and second            stationary plates to thereby actuate the plurality of blades            to vary the diameter of the channel.

3. The crimping device of example 1 or 2 wherein the second slots definean arcuate path with a first end and a second end spaced closer to thechannel than the first end.

4. The crimping device of any one of examples 1-3 wherein the diameterof the channel varies along the central axis.

5. The crimping device of any one of examples 1-4 wherein the bladeshave inner surfaces that define the channel, and wherein the innersurfaces are shaped such that the channel has a generally funnel-likeshape.

6. The crimping device of any one of examples 1-5 wherein the pluralityof blades includes twelve blades.

7. The crimping device of any one of examples 1-6 wherein—

-   -   the movable member has a first position in which the channel has        a maximum diameter,    -   the movable member has a second position in which the channel        has a minimum diameter, and    -   the pins are positioned radially farther from the central axis        in the first position than in the second position.

8. The crimping device of any one of examples 1-7, further comprising:

-   -   a frame; and    -   a holder removably coupled to the frame and configured to hold        the medical device within the channel as the blades reduce the        diameter of the medical device.

9. The crimping device of example 8 wherein—

-   -   the movable member has a first position and a second position,    -   the channel has a smaller diameter in the second position than        in the first position, and    -   the holder includes a plurality of fingers configured to engage        a portion of the medical device in the first position and        configured to disengage from the portion of the medical device        in the second position.

10. The crimping device of any one of examples 1-9 wherein the firstslots define a straight path that extends radially away from the centralaxis.

11. The crimping device of any one of examples 1-10 wherein the secondslots have a length that is longer than a length of the first slots.

12. The crimping device of any one of examples 1-11 wherein the firstslots and second slots are equally spaced angularly around the centralaxis.

13. The crimping device of any one of examples 1-12, further comprisinga connector coupled to the movable member and having a threaded holeextending therethrough, wherein—

-   -   the movable member is a rotatable member,    -   the actuator device is a threaded shaft and extends through the        threaded hole of the connector, and    -   actuating the rotatable member includes rotating the threaded        shaft about a longitudinal axis of the shaft such that the        connector moves along the shaft.

14. The crimping device of any one of examples 1-13 wherein the channelis configured to receive a prosthetic heart valve device forimplantation into a native mitral valve, and wherein the blades areconfigured to reduce an outer diameter of the prosthetic heart valvedevice from 1.300 inches to 0.4 inch or less.

15. A system for reducing a size of a stent device, the systemcomprising:

-   -   a crimping device including—        -   a frame having a stationary plate having a plurality of            first slots,        -   a movable member having a plurality of second slots, wherein            the movable member is movable with respect to the stationary            plate,        -   a plurality of movable blades arranged circumferentially to            define a channel having a central axis extending            therethrough, wherein—            -   the channel is configured to receive a prosthetic heart                valve device in an unexpanded state,            -   the movable member is between the blades and the                stationary plate,            -   each blade has a first end portion and a second end                portion spaced radially farther from the central axis                than the first end portion,            -   each blade includes a pin projecting from the second end                portion and extending through one of the first slots and                a corresponding one of the second slots, and        -   an actuator device configured to move the movable member to            drive the plurality of blades between a first position in            which the channel has a first cross-sectional dimension to a            second position in which the channel has a second            cross-sectional dimension smaller than the first            cross-sectional dimension, wherein moving the blades from            the first position to the second position decreases an outer            dimension of the stent device, and wherein the first slots            are configured to maintain relative position between the            blades as the blades move between the first and second            positions; and    -   a holder removably coupled to the frame and configured to hold        the stent device within the channel when the blades are in the        first position.

16. The system of example 15 wherein the blades are configured tocontinuously compress the prosthetic heart valve device as the bladesmove from the first position to the second position.

17. The system of example 15 or 16 wherein the channel has a funnelshape.

18. The system of any one of examples 15-17, further comprising a traydefining a reservoir that is configured to receive the crimping devicetherein.

19. The system of example 18 wherein the reservoir is configured to holda chilled liquid therein, and wherein the liquid fills the channel whenthe crimping device is positioned within the reservoir.

20. The system of example 18 wherein the tray includes an apertureextending through the tray to the reservoir, wherein the channel of thecrimping device is accessible via the aperture to permit the prostheticheart valve device to be positioned within the channel.

21. The system of any one of examples 15-20 wherein—

-   -   the holder includes a plurality of fingers configured to engage        attachment features of the prosthetic heart valve device in the        first position; and    -   the blades are sized and shaped to press against the fingers as        the blades move from the first position to the second position        to disengage the attachment features from the holder.

22. The system of any one of examples 15-21 wherein, in the firstposition, the pins are positioned radially farther from the central axisof the channel than in the second position.

23. A method for reducing a size of a medical device for loading into adelivery capsule, comprising:

-   -   positioning the medical device within a channel of the crimping        device, wherein—        -   the channel is defined by a plurality of movable blades            arranged circumferentially around a central axis of the            channel,        -   each blade includes a pin projecting from an end portion of            the blade spaced radially apart from the channel, and        -   each pin projects through a first slot on a stationary plate            and a second slot on a movable member positioned between the            stationary plate and the blades; and    -   driving the blades radially inwardly from a first position to a        second position to reduce a cross-sectional dimension of the        channel, thereby reducing an outer diameter of the medical        device, wherein driving the blades includes moving the movable        member relative to the stationary plate to move the pins along        individual arcuate paths defined by the corresponding second        slots.

24. The method of example 23 wherein driving the blades radiallyinwardly comprises driving the blades from the first position in whichthe channel has a minimum cross-sectional dimension of at least 1.300inches to the second position in which the channel has a minimumcross-sectional dimension of at most 0.4 inch.

25. The method of example 23 or 24 wherein driving the blades radiallyinwardly comprises moving each pin from a first end of the arcuate pathtoward a second end of the arcuate path, wherein the second end iscloser to the central axis of the channel than the first end.

26. The method of any one of examples 23-25 wherein driving the bladesradially inwardly comprises continuously compressing the medical device.

27. The method of any one of examples 23-26 wherein the medical deviceis a prosthetic heart valve device, and wherein the method furthercomprises:

removably coupling a plurality of engagement features of the prostheticheart valve device to a corresponding plurality of fingers of a holder,wherein the holder retains the prosthetic heart valve device while theblades are in the first position; and

-   -   wherein driving the blades radially inwardly presses the blades        against outer surfaces of the fingers to disengage the        engagement features from the holder.

28. The method of any one of examples 23-27 wherein the blades haveinner surfaces that define the channel, wherein the inner surfaces areshaped such that the channel has a generally funnel-like shape, andfurther comprising:

after driving the blades to the second position, moving the medicaldevice through the channel toward the delivery capsule to further reducean outer diameter of the medical device.

29. The method of any one of examples 23-28, further comprisingsubmerging the crimping device in a liquid such that the medical deviceis submerged when positioned within the channel.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example,although steps are presented in a given order, alternative embodimentsmay perform steps in a different order. The various embodimentsdescribed herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with some embodiments of the technology have been describedin the context of those embodiments, other embodiments may also exhibitsuch advantages, and not all embodiments need necessarily exhibit suchadvantages to fall within the scope of the technology. Accordingly, thedisclosure and associated technology can encompass other embodiments notexpressly shown or described herein.

What is claimed is:
 1. A holder for holding a medical device duringcrimping of the medical device, the holder comprising: an annular base;a central opening extending through the annular base, the centralopening defining a central axis; and a plurality of fingers arrangedcircumferentially around the central axis extending through the centralopening, wherein the plurality of fingers are configured to engage themedical device at more than one point around a circumference of themedical device.
 2. The holder of claim 1, wherein the annular basedincludes a first side, a second side, a radially inner surface, and aradially outer surface, and wherein a portion of each of the pluralityof fingers extends away from the second side of the annular base.
 3. Theholder of claim 2, wherein each of the plurality of fingers includes anindex feature extending inwardly from the portion, the index featureshaped to engage a portion of the medical device.
 4. The holder of claim3, wherein the index feature has a generally V-like shape.
 5. The holderof claim 3, wherein the index feature has a shape corresponding to ashape of cells of the medical device.
 6. The holder of claim 4, whereinthe index feature has a corresponding shape and arrangement to mate withthe cells of the medical device that are rectangular, sinusoidal,triangular, or polygonal.
 7. The holder of any one of claims 1-6,wherein the plurality of fingers are flexible such that the fingers bendradially inward or outward in response to external forces applied to thefingers.
 8. The holder of any one of claims 1-6, wherein the pluralityof fingers comprises exactly twelve fingers.
 9. The holder of any one ofclaims 2-6, wherein the radially outer surface of the annular baseincludes grooves and/or ridges configured to make the holder easy togrip and manipulate.
 10. The holder of any one of claims 1-6, whereinthe annular base further includes connectors configured to removablycouple the holder to a crimping device.
 11. The holder of claim 1,wherein the plurality of fingers includes a plurality of first fingersand a plurality of second fingers.
 12. The holder of claim 11, whereineach of the plurality of first fingers includes a first longitudinalportion and each of the plurality of second fingers includes a secondlongitudinal portion, wherein the first longitudinal portion is spacedfarther from the central longitudinal axis that the second longitudinalportion.
 13. The holder of claim 11, wherein each of the plurality offirst fingers includes a first longitudinal portion and an index featureextending radially inwardly from the first longitudinal portion, theindex feature shaped to engage a portion of the medical device.
 14. Theholder of claim 11, wherein each of the plurality of second fingersincludes a second longitudinal portion and a second portion extendingradially inward from the second longitudinal portion, the second portionshape and position to receive a portion of the medical device.
 15. Theholder of claim 11, wherein each of the plurality of first fingersincludes a first portion extending radially inward from the innersurface of the base toward the central longitudinal axis, a secondportion extending from the first portion and away from a side of theannular base, a third portion extending from the second portion andradially inward toward the central longitudinal axis, and a fourthportion configured to engage the medical device.
 16. The holder of claim15, wherein the plurality of second fingers includes a first portionextending radially inward from the inner surface of the base toward thecentral longitudinal axis, a second portion extending from the firstportion and away from the side of the annular base, and a third portionextending from the second portion and radially inward toward the centrallongitudinal axis.